Hygiene Management System Procedures

HYGIENEMANAGEMENT SYSTEM

Approved By Management rep

Signature

Position

Approval Date

Current Revision

Contents

Title page 1

Contents 2

Organisation structure 3

Food packaging safety policy 4

Glass policy 5

Blade policy 6

HP 1.1 Hazard analysis procedure 7

HP 1.2 Medical review procedure 8-9

HP 1.3 Hygiene training procedure 10-11

HP 1.4 Contamination control procedure 12

HP 1.5 Glass and brittle plastic control procedure 13-14

HP 1.6 Blade control procedure 15-16

HP 1.7 Cleaning procedure 17

HP 1.8 Pest control procedure 18-19

HP 1.9 Food contact compliance procedure 20

HP 1.10 Product recall procedure 21-22

HP 1.11 Emergency procedure 23

HP 1.12 Microbiological audit procedure 24-25

HP 1.13 GMP / GHP audit procedure 26-27

HP 1.14 Hygiene review procedure 28-29

HP 1.15 Traceability plan 30

HP 1.16 Transport Hygiene procedure 31

Quality records 32

HM1 Revision 1issue: 01.01.01

Page 2 of 32

Organisation Structure


Page 3 of 32

Food Packaging Safety Policy

General Policy Statement---------------. recognise our duties and accept our responsibilities for ensuring the continued safety of our packaging for use with food products.

Policy Objectives---------------- are committed to making sure that the highest standards of food packaging safety and hygiene are maintained and will, so far as is reasonably practicable comply with food packaging safety requirements. All reasonable precautions will be taken and due diligence exercised regarding food packaging safety.

We achieve this by ensuring that all raw materials purchased comply with current legislation and regulations, and by maintaining a management system that satisfies the requirements of The British Retail Consortium / Institute of Packaging Technical Standard and Protocol for Companies Manufacturing and Supplying Food Packaging Materials for Retailer Branded Products.

Responsibilities The Managing Director is responsible for ensuring continued commitment to food packaging

safety within the organisation and for providing the necessary resources.

The Technical Manager is the Management Representative on all matters relating to Food Packaging Safety and is responsible for the implementation and maintenance of the management system and for reporting on the effectiveness of the management system to management review.

The Quality Manager is the Deputy Management Representative and is tasked with the Management Representatives duties in his absence.

All Managers and Supervisors will ensure that, in departments or for processes for which they are responsible, the arrangements detailed in this policy are implemented and compliance with all food packaging safety controls and procedures are maintained.

All employees are responsible for complying with ------------------ food packaging safety procedures and for reporting to management anything that may compromise food packaging safety.

TrainingAll new personnel will receive appropriate induction training concerning the company hygiene rules and potential food packaging safety hazards before commencing work. Further and refresher training will be carried out where required, based on the results of internal audits and inspections.

Review

This policy will be reviewed annually by the Managing Director.

Approval

This policy was approved on ---------------------

----------------


Page 4 of 32

Managing Director

Glass PolicyIt is our policy to continually minimise the risk of product contamination by glass and brittle plastics.

Glass and plastic with similar brittle qualities is excluded wherever possible from the factory. Where no satisfactory alternative can be found to glass or brittle plastic, articles are protected in a manner, which will prevent shattering, or completely contain shattered fragments.

It is the company policy to provide continual monitoring of glass and brittle plastic articles within the factory.

-----------------------Managing Director


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Blade PolicyIt is our policy to continually minimise the risk of product contamination from blades and other sharp objects.

Blade control procedures are provided covering the issue, return and disposal of blades and the action required should an incident occur.

------------------------Managing Director


Page 6 of 32

HP 1.1 Hazard analysis procedure1.0 Purpose

1.1 To describe the process for identifying all food safety hazards that are present within the production process.

1.2 To ensure that where necessary control measures are implemented, maintained and regularly reviewed.

2.0 Scope

2.1 Covers the supply chain process from raw material purchase to delivery of product to the customer.

3.0 Documents

HACCP Manual QD 16.7Hazard Chart QD 16.25

4.0 Definitions

HACCP - Hazard Analysis Critical Control Points

5.0 Procedure

5.1 HACCP study

5.1.1 The HACCP team conduct a hazard analysis considering all microbiological, foreign objects and chemical contamination, as well as packaging defects critical to consumer safety that may reasonably be expected to occur during the production processes.

5.1.2 The hazards along with the appropriate control and monitoring measures are detailed in the HACCP Manual QD 16.7 and on Hazard Charts QD 16.25, which are displayed in production departments.

5.1.3 All employees are provided with HACCP awareness training within 1 month of joining the company.

5.1.4 A review of the HACCP is carried out by the HACCP team every 12 months or whenever a ‘significant’ process change is made.


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HP 1.2 Medical review procedure1.0 Purpose

1.1 To describe the personnel 'medical review' systems.

2.0 Scope

2.1 Medical screening includes:

Medical questionnaire for prospective production personnel Colour blindness assessment for prospective print personnel Health questionnaire for visitors and contractors Reporting illness at work

3.0 Documents

Visitors Questionnaire QD 16.1Hygiene Code of Practice QD 16.23Pre Employment Medical Questionnaire QD 16.30Guidance Notes For Pre Employment Medical Questionnaire QD 16.31Colour Blindness Assessment Record QD 22.2

4.0 Definitions

NONE.

5.0 Procedure

5.1 Medical screening requirements for intended production personnel

5.1.1 Before an applicant can be considered for employment in any production area of the factory they must satisfactorily complete a Pre Employment Medical Questionnaire QD 16.30.

5.1.2 The Guidance Notes for Pre Employment Medical Questionnaire QD 16.31 should be used by the Department Head to determine whether the applicant has met the requirements.

5.2 Colour blindness assessment requirements for intended print personnel

5.2.1 Before an applicant can be considered for employment in the Print Department they must successfully complete a colour blindness assessment.

5.2.2 The colour blindness assessment must be carried out using the Ishihara Design Chart Book and the results must be recorded on Colour Blindness Assessment Record QD 22.2.


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5.3 Medical screening requirements for visitors

5.3.1 All visitors/contractors intending to enter production areas of the factory must complete a Visitors Questionnaire QD 16.1.

5.3.2 If ‘yes’ is answered to any of the questions on the Visitors Questionnaire QD 16.1 entry to production areas may not be permitted and the ----------------- Department must be contacted for guidance.

5.3.3 An employee escorting the visitor/contractor during their time 'on site' is responsible for communicating all relevant hygiene requirements and for ensuring that they are fully complied with. See Hygiene Code of Practice QD 16.23.

5.4 Reporting illness at work

5.4.1 All employees employed in production areas of the factory are required to report illness/medical conditions to Management as detailed in the Hygiene Code of Practice QD 16.23.

5.5 Confidentiality

5.5.1 All personnel medical records are strictly private and confidential and should be maintained in a secure place by the Department head.


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HP 1.3 Hygiene training procedure

1.0 Purpose

1.1 To specify the requirements for hygiene training of personnel.

1.2 To ensure that all employees understand all hygiene requirements and food safety hazards appropriate to their work activity.

2.0 Scope

2.1 Applies to all personnel.

3.0 Documents

Introduction to Company (induction pack) QD 17.1In Depth Hygiene Training (Contamination control) QD 17.30Group Training Record QD 17.16Hygiene Code of Practice QD 16.23

4.0 Definitions

NONE.

5.0 Procedure

5.1 Hygiene training - Induction

5.1.1 All new personnel receive induction training before commencing work. Induction training includes:

policies (Hygiene, glass, blade) food industry briefing description of risk areas hygiene Code of Practice gowning procedures contamination Control

5.1.2 New employees are provided with a copy of Hygiene Code of Practice QD 16.23. The code of practice is a comprehensive guide to the hygiene requirements.

5.2 In depth hygiene training

5.2.1 All production personnel are provided with in depth hygiene training within one month of joining the company, the training includes:

introduction to hygiene preventing product contamination


Page 10 of 32

background to the UK Food Hygiene Regulations HACCP system the employees responsibility the companies role in the food chain

5.3 Additional hygiene training

5.3.1 Additional refresher hygiene training is developed and carried out as required the timing and content of further training is based on risk and the results of internal hygiene audits.


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HP 1.4 Contamination control procedure1.0 Purpose

1.1 To describe the process for reporting contamination and the action required should an incident occurs.

2.0 Scope

2.1 This procedure applies to all contaminants excluding glass and brittle plastic and blades, which are covered by separate procedures.

3.0 Documents

Contamination Incident Report QD 16.26

4.0 Definitions

NONE.

5.0 Procedure

5.1 Contamination identification

5.1.1 All production employees are provided with training in the avoidance and detection of contaminants.

5.1.2 It is a requirement of the Hygiene Code of Practice for employees to report all contamination incidents to Management.

5.2 Contamination incident action and investigation

5.2.1 It is the responsibility of the Department Head, Chargehand or Supervisor who is initially notified of a contamination incident to assume the role of ‘Incident Manager’ and to follow the instructions on the Contamination Incident Report QD 16.26.

5.2.2 Special procedures detailing the action required following a glass, ceramic or brittle plastic breakage are detailed in Glass and brittle plastic control procedure HP 1.5.

5.2.3 Special procedures detailing the action required following the loss of a blade/part of a blade are detailed in Blade control procedure HP 1.6.


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HP 1.5 Glass and brittle plastic control procedure 1.0 Purpose

1.1 To ensure that glass and brittle plastic is adequately controlled.

1.2 To describe the process for reporting glass and brittle plastic breakage's and the action required if an incident occurs.

2.0 Scope

2.1 Applies to all glass and brittle plastic articles at the factory which have been registered as requiring continuous monitoring and control.

3.0 Documents

Glass and Brittle Plastics Register QD 16.3Manufacturing Facility Lighting Audit QD 16.18Glass And Brittle Plastic Breakage Incident Report QD 16.20

4.0 Definitions

‘Glass’ includes ceramic articles.

5.0 Procedure

5.1 Precautionary measures

5.1.1 Employees are not allowed to bring glass or glass containing items into any of the ‘risk areas’. Such items include watches, jewellery, mirrors, compacts, thermos flasks, tumblers, bottles, jars, laboratory equipment etc.

5.1.2 All forms of electric lighting (including electric fly killers) in ‘risk areas’ must have the tube or bulb encased in a clear shatterproof housing or coated with a layer of shatter resistant material.

5.1.3 Where possible in all other areas of the factory lighting must be progressively replaced with shatterproof or protected lighting as opportunities present themselves.

5.1.4 Inspection lamps, replacement fluorescent tubes etc. must be fully encased by protective covering when being carried through a ‘risk area’. Unless absolutely necessary work involving these items must not be carried out whilst production is in progress.

5.1.5 Ideally, windows in ‘risk areas’ should be constructed of a suitable polycarbonate material. Existing glass windows must therefore be progressively replaced as opportunities present themselves, e.g. cracked or broken panes.


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5.1.6 Where possible glass contained in plant and equipment, e.g. instrument panels, pressure gauges, thermometers, warning/signal lamps should be replaced with a shatterproof alternative and before purchasing any equipment, arrangements must be made for components to be replaced with suitable alternatives.

5.1.7 It is the responsibility of personnel to ensure that glasses and contact lenses worn in ‘risk areas’ remain intact. In the event of any breakage or loss the procedures in 5.3shall apply.

5.2 Glass and brittle plastics auditing

5.2.1 The ----------------- Department is responsible for recording the location of every item of glass or brittle plastic in the factory ‘risk areas’ on Glass and Brittle Plastics Register QD 16.3.

5.2.2 The ------------------ Department carries out a monthly audit of glass and brittle plastic. The results are recorded on the Glass And Brittle Plastics Register QD 16.3.

5.2.3 The -------------------- Manager reviews results of audits and initiates any required corrective action.

5.2.4 The site electrician carries out an audit of all factory lighting every three years. The purpose of the audit is to ensure that all lighting in 'risk areas' remains shatterproof or protected and to indicate the condition of lighting in all other areas of the factory. Results of audits are recorded on Manufacturing Facility Lighting Audit QD 16.18.

5.3 Glass and brittle plastic breakage action and investigation

5.3.1 It is a requirement of the Hygiene Code of Practice for employees to report all glass and brittle plastic breakage's to Management.

5.3.2 It is the responsibility of the Department Head, Chargehand or Supervisor who is initially notified of a glass or brittle plastic breakage to assume the role of ‘Incident Manager’.

5.3.3 On notification of a breakage the Incident Manager must retrieve the ‘Glass Breakage Kit’ and follow all the instructions on the Glass And Brittle Plastic Breakage Incident Report QD 16.20.


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HP 1.6 Blade control procedure1.0 Purpose

1.1 To ensure that all blades are adequately controlled.

1.2 To describe the process for reporting blade damage or loss and the corrective action required if an incident occurs.

2.0 Scope

2.1 This procedure applies to all factory departments.

2.2 This procedure applies to all types of knife and knife blades in use within the factory.

3.0 Documents

Master Knife Control Record QD 16.19Blade Control Record QD 16.17

4.0 Definitions

NONE.

5.0 Procedure

5.1 Knife identification

5.1.1 Only knives issued by the company are authorised for use within the factory.

5.1.2 An approved knife may be:

Automatic Retractable (AR) Folding Pen knife (FP) Sheath (SH) Scalpel (SC)

5.1.3 All knives are identified by a ‘knife identification code', which is engraved on the knife body. The knife identification code allows the knife to be traced to the employee issued with the knife.

5.2 Authority to issue

5.2.1 Knives and blades may only be issued by a Department Head, Chargehand or Supervisor.


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5.3 Knife issue

5.3.1 The details of each knife issued must be recorded on the Master Knife Control Record QD 16.19 by the issuer.

5.4 Blade issue

5.4.1 When a new knife blade is required the employee must take their knife to a Supervisor for a replacement blade to be fitted.

5.4.2 In an emergency an employee may have a knife blade issued by a Supervisor from another department.

5.4.3 The Supervisor must inspect the returned blade to ensure it is intact and not damaged.

5.4.4 If the returned blade is intact then the Supervisor must fit a new blade and dispose of the returned blade in the sharps bin.

5.4.5 The details of each blade issued and returned must be recorded on the Blade Control Record QD 16.17 by the issuer.

5.4.6 If an employee has lost a blade or the blade is returned damaged i.e. chipped or snapped, the procedure in 5.6 must be followed.

5.5 Knife and blade care

5.5.1 It is the responsibility of employees to take care of the knife and blade they are issued with. Knives must never be lent to other personnel.

5.5.2 Employees must not take their knife off the premises under any circumstances.

5.5.3 Any loss or damage to a knife blade must be reported to Management immediately.

5.6 Action for loss or damaged blade

5.6.1 If Management believe that the blade loss or damage poses a significant risk of product contamination, work must be stopped in the area until a review is carried out:

5.6.2 A team of personnel must carry out a search of the area (including product if necessary) for the missing blade/part of blade.

5.6.3 If the search proves unsuccessful a decision must be made whether a more thorough search is required and whether product needs to be rejected or reworked.

5.6.4 If there is a risk that contaminated product may have been despatched to the customer then a Director may instigate the Product Recall Procedure HP 1.10.

5.6.5 As soon as immediate action is completed the Supervisor must record the details of the incident on Blade Control Record QD 16.17 this must include the batch ID code of any product involved.


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HP 1.7 Cleaning procedure1.0 Purpose

1.1 To describe the cleaning program that is operated to maintain the hygienic conditions in all areas of the factory.

2.0 Scope

2.1 This procedure applies to all departments within the factory.

3.0 Documents

Facilities Cleaning Schedule QD 16.13Facilities Cleaning Checklist QD 16.14Department 1 Cleaning Schedule QD 16.35Department 1 Cleaning Record QD 16.37Engineering Hygiene Clearance Record QD 16.38Department 2 Cleaning Record QD 16.41Factory Cleaning Schedule QD 16.42Department 3 Cleaning Record QD 16.43Vehicle Weekly Cleaning Record QD 16.44

4.0 Definitions

NONE.

5.0 Procedure

5.1 Cleaning Schedule

5.1.1 A Factory Cleaning Schedule QD 16.42 is maintained which specifies the following:

Area/item to be cleaned Frequency Cleaning product Tools Method Responsibility for completion

5.1.2 All cleaning completed must be recorded on the relevant cleaning record.


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HP 1.8 Pest control procedure1.0 Purpose

1.1 To describe the pest control contract that is operated to prevent infestation and to maintain the hygienic conditions in all areas of the factory.

2.0 Scope

2.1 Covers all areas of the factory.

3.0 Documents

NONE.

4.0 Definitions

EFK - Electric Fly Killer

5.0 Procedure

5.1 Responsibility

5.1.1 It is the responsibility of the ----------------- to liaise with the pest control supplier on all aspects of the contract.

5.2 Pest control contract

5.2.1 The pest control contract consists of:

8 Routine visits per annum 4 Inspection visits per annum 4 EFK services per annum 4 EFK catch tray analysis

5.2.2 An annual schedule of dates for all visits is agreed between the company and the pest control supplier and is maintained in the pest control manual.

5.2.3 All internal bait traps used must be non toxic.

5.3 Routine visits

5.3.1 At the routine visit the pest control technician checks all bait traps for rodent activity. The bait traps are changed/cleaned as required and dated.


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5.3.2 The technician checks all the insect detectors for insect activity and replaces them as required.

5.3.3 The technician checks the stacking of product, access and general housekeeping within the factory.

5.4 Inspection visits

5.4.1 At the inspection visit the field biologist carries out an in depth inspection of the pest control systems at the factory.

5.4.2 The ----------------------- must accompany the Field Biologist on at least one of the inspection visits each year.

5.5 EFK servicing

5.5.1 EFK’s bulbs are changed annually with shatterproof tubes.

5.3.2 In production areas of the factory all EFK’s must be positioned so that debris cannot fall onto open product.

5.5.3 At the EFK services the machines are cleaned and the catch trays are replaced as required.

5.5.4 The pest control supplier carries out catch tray analysis at each EFK service to identify trends/ problem areas with flying insects.

5.6 Call out

5.6.1 If any member of staff discovers an infestation of any type they must immediately notify the ---------------------.

5.6.2 The ---------------------- must contact the pest control supplier to call out a Technician the same day if possible.

5.6.3 Call out is available 24 hours a day 365 days per annum for rat, mice and crawling and biting insect's infestations.

5.7 Corrective action

5.7.1 Following all pest control visits, the findings and recommendations for improvement or corrective action taken must be discussed with the ------------------------------- and recorded in the pest control manual.

5.7.2 The ---------------------- must ensure that all recommendations for corrective action are completed in a timely manner and are signed off when completed.


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HP 1.9 Direct food contact compliance procedure

1.0 Purpose

1.1 To ensure that all raw materials meet relevant UK and European legislation for direct food contact packaging and is suitable for intended use.

2.0 Scope

2.1 Covers all standard raw material in use.

3.0 Documents

NONE.

4.0 Definitions

NONE.

5.0 Procedure

5.1 Direct food contact compliance

5.1.1 All standard raw material in use is approved for direct food contact and meet the requirements of Acts, regulations and orders applicable in the United Kingdom and all regulations made as a result of the requirements of EC Directives and regulations.

5.1.2 It is the responsibility of suppliers to ensure the materials continued approval status.

5.1.3 As a minimum, for each raw material specification the following certificates are maintained:

Material specification agreed between the Supplier and the Company. Annual certificate of conformity Food contact approval statement Migration certificate Heavy metal clearance certificate

5.1.4 All specifications and certificates are reviewed and validated annually. See Raw material assessment and approval procedure QP 3.1.


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HP 1.10 Product recall procedure1.0 Purpose

1.1 To describe the process for recalling product from the supply chain following an incident that poses a significant risk of product contamination.

2.0 Scope

2.1 Applies to all products and personnel.

3.0 Documents

Product Recall Incident Report QD 16.24

4.0 Definitions

NONE.

5.0 Procedure

5.1 Contamination incident reporting

5.1.1 If for any reason an employee believes that contaminated product may have been despatched to customer(s) they must report the incident immediately to a member of Management.

5.1.2 The member of Management notified must inform relevant personnel of the incident including at least one Director.

5.1.3 Internal discussions must take place in order to determine whether the reported contamination poses a significant risk to product and whether the product recall process should be instigated.

5.2 Recall process

5.2.1 A senior member of Management must assume the role of ‘Product Recall Manager’.

5.2.2 The Product Recall Manager has the authority to instigate any necessary action in order to reduce the risk of contaminated product being used by customers.

5.2.3 The Product Recall Manager must organise relevant personnel to form a ‘Product Recall Team’ and delegate tasks as required.

5.2.4 All actions carried out during the product recall must be recorded by the Product Recall Manager on Product Recall Incident Report QD 16.24.


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5.3 Instructions - immediate action

5.3.1 Carry out a thorough investigation to identify all potentially contaminated product within the supply chain i.e. product on site at customers and product in transit to customers.

5.3.2 Ask relevant customers to reject all potentially contaminated products on site and in transit.

5.3.3 It may be necessary to notify other interested parties that may include:

Environment Agency Raw material suppliers The Press

5.4 Instructions - follow up action

5.4.1 Arrange urgent replacement product for customers and arrange for the return of affected product.

5.4.2 When recalled product is returned to must be identified with Reject Stickers QD 13.4 and place in quarantine.

5.4.3 Returned recalled product must be handled as a customer complaint. (See Customer complaints procedure QP 12).

5.5 Product recall test

5.5.1 The effectiveness of the product recall procedure is tested annually by the -----------Department and the results are recorded on Product Recall Incident Report QD 16.24.


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HP 1.11 Emergency procedure

1.0 Purpose

1.1 To ensure that key personnel are available in an emergency.

2.0 Scope

2.1 For the purpose of this procedure an emergency is taken to mean any incident that seriously compromises the hygiene or safety of product, personnel or premises.

3.0 Documents

NONE.

4.0 Definitions

NONE.

5.0 Procedure

5.1 Business hours

5.1.1 ------------------ normal business hours are:

Monday - Friday 8.30 a.m. to 5.00 p.m., excluding all public and bank holidays in England and Wales and the company shut down over the Christmas and New Year period.

5.2 Out of hours-emergency contacts

5.2.1 If an emergency occurs outside of normal business hours any one of the following key personnel may be contacted by mobile phone:

Name, position - number Name, position - number Name, position - number

5.3 Emergency action

5.3.1 In an emergency the contact must notify relevant parties that may include, Senior Management, the emergency services environment agency, raw material suppliers and the press.

5.3.2 If product threat exists it may be necessary to initiate a product recall (See Product recall procedure HP 1.10).


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HP 1.12 Microbiological audit procedure1.0 Purpose

1.1 To describe the microbiological audit process.

1.2 To provide assurance that the Hygiene Management System continues to provide adequate levels of hygiene in all production areas of the factory.

2.0 Scope

2.1 Applies to the --------------------------- who is responsible for managing all ‘microbiological audit’ activities.

2.2 Covers all areas of the factory.

3.0 Documents

Quarterly Microbiological Audit Report

4.0 Definitions

NONE.

5.0 Procedure

5.1 Microbiological audit contract

5.1.1 A formally accredited supplier carries out microbiological audits every 3 months at ---------------- factory.

5.1.2 It is the responsibility of the -------------------- to liaise with the microbiological audit supplier concerning all aspects of the contract including the audit schedule.

5.1.4 The -------------------- must accompany the microbiological audit supplier on at least one of the quarterly audits each year.

5.2 Microbiological audit

5.2.1 The microbiological audit consists of the following testing:

Environmental swabs Hand swabs Product swabs Atmospheric settle plate analysis

5.2.3 The microbiological audit identifies the presence and levels of the following microorganisms:


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Yeasts Moulds Enterobacteriaceae Staphylococcus aureus Listeria Salmonella

5.2.4 Within two weeks of the audit the supplier provides a comprehensive report detailing the findings of the audit and any corrective action required.


5.3.1 The ------------------- is responsible for ensuring that all recommendations for corrective action are completed in a timely manner.

5.3.2 Corrective action may include:

A review of relevant hygiene procedures A reiteration of hygiene procedures An increase in the frequency of microbiological audits

.


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HP 1.13 GMP / GHP audit procedure

1.0 Purpose

1.1 To describe the process for carrying out GMP / GHP audits of the factory.

1.2 To verify conformance with manufacturing / hygiene procedures, HACCP requirements and to determine the general levels of hygiene.

1.3 To describe how GMP / GHP audits are conducted, how observations are recorded and how appropriate corrective actions are agreed, implemented and verified.

2.0 Scope

2.1 Covers the manufacturing site.

3.0 Documents

GMP / GHP Audit Checklist QD 16.8

4.0 Definitions

GMP - Good Manufacturing PracticeGHP - Good Hygiene PracticeHACCP - Hazard Analysis Critical Control Points

5.0 Procedure

5.1 General

5.1.1 The ------------------- is responsible for carrying out GMP / GHP audits every 3 months in accordance with this procedure and for maintaining records of the findings.

5.1.2 The -------------------- is responsible for ensuring that GMP / GHP audits are carried out by appropriately trained personnel who are independent of the function / area audited.

5.2 Audit planning/preparation

5.2.1 GMP / GHP audits are carried out using GMP / GHP Audit Checklist QD 16.8.

5.2.2 Prior to the audit the auditor must review relevant information e.g. results of previous audits, relevant procedures and HACCP requirements e.g. CCP's.

5.2.3 Attention must be given to ‘Observations’ from previous GMP / GHP Audits in order to verify effectiveness of corrective action.


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5.3 Audit investigation

5.3.1 During the audit the auditor verifies conformance with each item on the GMP / GHP Audit Checklist QD 16.8 and records all observations in order to provide a complete record of the audit.


5.4.1 On completion of the audit the auditor must discuss any observations resulting from the audit with the Department Head and agree any corrective action.

5.4.1 Each observation and the corrective action required are reviewed on the basis of potential risk to the product (e.g. contamination, quality).

5.4.2 Where significant risk is presented completion dates for corrective action must be agreed and the auditor must verify completion of the corrective action.

5.4.4 Verification of all other corrective actions is carried out at the next audit.

5.5 Hygiene review meetings

5.5.1 Results of GMP / GHP audits are reported at hygiene review meetings. (See Hygiene Review Procedure HP 1.2).


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HP 1.14 Hygiene review procedure1.0 Purpose

1.1 To describe the process for reviewing the effectiveness of the Hygiene Management System at defined intervals.

1.2 To determine what changes may be necessary to ensure the continuing suitability and effectiveness of the Hygiene Management System in meeting the aims and objectives set out in the Hygiene Policy.

2.0 Scope

2.1 Applies to the -------------------------- who is responsible for scheduling and reporting to Hygiene Review Meetings.

2.2 The hygiene review meeting forms a part of the monthly Department Head Quality Meeting.

3.0 Documents

Management Review Meeting - Report

4.0 Definitions

NONE.

5.0 Procedure

5.1 Responsibilities

5.1.1 The --------------------------- has overall responsibility for ensuring that Hygiene Reviews are conducted effectively and for:

Advising the Hygiene Review Team on the frequency of Hygiene Reviews (At least every 3 months).

Making all necessary arrangements for holding the meetings.

Preparing and circulating any necessary documents and information before the meeting.

Acting as secretary to the Hygiene Review Meetings including recording the proceedings.

Ensuring that any corrective, preventive or other actions are implemented.


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5.2 Hygiene Review agenda

5.2.1 The agenda includes a review of:

Previous minutes and corrective actions Compliance to BRC standard GMP / GHP audits Customer audits Supplier audits Contamination issues Microbiological audit Pest control Legislative issues Corrective/preventive action taken or proposed

5.3 Hygiene review minutes

5.3.1 It is the responsibility of the ------------------------- to provide minutes of the meeting detailing any actions required along with completion dates.

5.4 Follow up

5.4.1 Follow up of corrective action is carried out by the ---------------------- and reported at the next Hygiene Review Meeting.


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HP 1.15 Traceability plan1.0 Purpose

1.1 To define the process for tracing back to all required records (retained samples and production records).

2.0 Scope

2.1 Applies to all products manufactured.


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Retained documentation

Raw material label from each reel (includes supplier batch ID code) Production Order (a record of production and includes information on material, machine, tools unit, operators and results of all In-process quality checks).

Retained for 12 months.

Retained samples Strip from each printed reel.

Retained for 12 months or 3 Works Orders.

Customer complaint or request for information

The critical number required to trace all relevant order information is the ’batch ID code’ which can be found on the ------------------.

Batch ID code e.g. 012345

Supplier recordsThe critical number required by the supplier to trace all relevant order information is the ‘batch ID number’ which can be found on the raw material label, this allows the supplier to trace to base materials (plastic, paper, lacquers, primers, machine, operators and results of in-process quality checks).

Retained for 24 months.

Investigations

Results ofInvestigation and feedback to customers

HP 1.16 Transport Hygiene procedure1.0 Purpose

1.1 To specify the requirements for incoming and outgoing vehicle hygiene inspections.

3.0 Scope

2.1 This procedure applies to raw material delivery and finished product despatch.

3.0 Documents

Incoming Vehicle & Load Checklist QD 6.10Outgoing Vehicle & Load Checklist QD 9.5

4.0 Definitions

NONE.

5.0 Procedure

5.1 Incoming Hygiene Inspection

5.1.1 All transportation vehicles arriving with deliveries of raw materials are subject to a hygiene inspection of (vehicle & load) by the Stores department prior to accepting and receiving the material.

5.1.2 The inspection must be carried out in accordance with the requirements detailed on Incoming Vehicle & Load Inspection Checklist QD 6.10.

5.2 Outgoing Hygiene Inspection

5.2.1 All transportation vehicles arriving to pick-up finished product are subject to a hygiene inspection by the Despatch department prior to loading the consignment.

5.2.2 The inspection must be carried out in accordance with the requirements detailed on Outgoing Vehicle Inspection Checklist QD 9.5.


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Quality records

Document title Ref. No.Latestrevision

Retention time years

Retained by department

Incoming Vehicle & Load Inspection Checklist QD 6.10 1 2 years Stores

Outgoing Vehicle Inspection Checklist QD 9.5 1 2 years Despatch

Visitors Questionnaire QD 16.1 3 2 years Reception

Glass and Brittle Plastics Register QD 16.3 1 5 years Technical

HACCP Manual QD 16.7 3 Indefinite Technical

GMP / GHP Audit Checklist QD 16.8 4 5 years Technical

Facilities Cleaning Schedule QD 16.13 2 2 years Dept 1

Facilities Cleaning Checklist QD 16.14 1 5 years Dept 1

Blade Control Record QD 16.17 1 5 years All depts.

Manufacturing Facility Lighting Audit QD 16.18 0 5 years Technical

Master Knife Control Record QD 16.19 2 5 years All depts.

Glass and Brittle Plastic Breakage Incident Report QD 16.20 1 5 years Technical

Hygiene Code Of Practice QD 16.23 2 N/A N/A

Product Recall Incident Report QD 16.24 1 5 years Technical

Hazard Chart QD 16.25 3 2 years Technical

Contamination Incident Report QD 16.26 0 5 years Technical

Pre Employment Medical questionnaire QD 16.30 1 Indefinite years

All depts.

Guidance For Pre Employment Medical Questionnaire QD 16.31 2 N/A N/A

Department 1 Cleaning Schedule QD 16.35 1 2 years Dept 1

Department 1 Cleaning Record QD 16.37 0 5 years Dept 1

Engineering Hygiene Clearance Record QD 16.38 0 5 years Engineers


Factory Cleaning Schedule QD 16.42 0 2 years Technical


Vehicle Cleaning Record QD 16.44 0 5 years Dept 3

Introduction To Company (induction pack) QD 17.1 1 N/A N/A

Group Training Record QD 17.16 1 Indefinite Technical

Colour Blindness Assessment Record QD 22.2 1 Indefinite Dept 2

Hygiene Review Meeting - Report N/A 1 Indefinite Technical

Quarterly Microbiological Audit – Report N/A 1 Indefinite Technical


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